Analytical Writer

ICON plc is a world-leading healthcare intelligence and clinical research organization. We re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development

We are looking for a highly skilled and experienced Bioanalytical Report Writer to join our team. The ideal candidate will have a background in clinical and preclinical studies, having worked in Clinical Research Organizations (CROs), and a solid understanding of bioanalytical techniques and regulatory guidelines. This role involves writing bioanalytical study reports based on data obtained from bioanalytical methods such as Sandwich and Bridging ELISA and LCMS. The candidate will also need expertise in FDA, EMA, and ICH M10 guidelines, particularly in relation to bioanalytical studies.

What You Will Be Doing:

• Write and compile bioanalytical study reports for clinical and preclinical research projects, ensuring clarity, accuracy, and compliance with regulatory standards.
• Interpret and analyze bioanalytical data from studies using methods such as Sandwich and Bridging ELISA and LCMS (Liquid Chromatography-Mass Spectrometry).
• Ensure bioanalytical reports are compliant with regulatory requirements including FDA, EMA, and ICH M10 guidelines, focusing on the quality, integrity, and consistency of the data.
• Collaborate closely with clinical, preclinical, and laboratory teams to obtain the necessary data for report writing.
• Provide feedback on bioanalytical data interpretation, making recommendations as necessary.
• Ensure that reports are written in accordance with Good Laboratory Practice (GLP), Good Clinical Practice (GCP), and other relevant guidelines.
• Review and edit reports for scientific accuracy, consistency, and regulatory compliance.
• Work with project managers to meet deadlines and deliver reports within the specified timelines.
• Prepare study-related documentation, including study protocols, raw data reports, and study final reports.
• Participate in discussions with internal and external stakeholders regarding study design, data collection, and data analysis.

Your Profile:

• Bachelor s or master s degree in Biochemistry, Biotechnology, Pharmacology, Clinical Research, or related fields.
• Minimum of 1-3 years of experience in bioanalytical report writing, particularly in clinical and preclinical settings.
• Experience working in a Clinical Research Organization (CRO) or similar laboratories.
• Strong knowledge of bioanalytical methods such as Sandwich and Bridging ELISA and LCMS.
• In-depth understanding of regulatory guidelines, including FDA, EMA, and ICH M10 for bioanalytical studies.
• Experience in writing and reviewing bioanalytical study reports in accordance with GLP, GCP, and other regulatory standards.
• Familiarity with clinical trial processes, pharmacokinetics, Pharmacodynamics , Immunogenicity and bioanalytical data analysis.
• Strong attention to detail and ability to interpret complex data and translate it into clear, concise reports.
• Excellent written and verbal communication skills.
• Ability to work independently, prioritize tasks, and manage time effectively in a fast-paced environment.

Preferred Skills:

• Experience with bioanalytical method validation and the interpretation of validation data.
• Knowledge of statistical analysis as applied to bioanalytical data.
• Familiarity with regulatory submission processes for bioanalytical reports.
• Experience in writing reports for regulatory filings and submission to agencies like the FDA and EMA.

What ICON can offer you:

Visit our careers site to read more about the benefits ICON offers.

At ICON, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. Were proud of our diverse workforce and the work we ve done to become a more inclusive organisation. We re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

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